In this blog I examine the effects of pharmaceutical marketing, inadequate regulations in healthcare, and poor health literacy on human health. I am a M.S. candidate in health policy at the Harvard School of Public Health with a M.A. in journalism from New York University. Follow me on Twitter: @gerganakoleva

Merck Whistleblower Suit A Boon to Vaccine Foes Even As It Stresses Importance of Vaccines

Anyone who falls on either side of the debate about vaccines’ alleged potential to cause harm is sure to have heard the big news this week — the unsealing of a whistleblower suit against Merck, filed back in 2010 by two former employees accusing the drugmaker of overstating the effectiveness of its mumps, measles, and rubella vaccine.

The scientists claim Merck defrauded the U.S. government by causing it to purchase an estimated four million doses of mislabeled and misbranded MMR vaccine per year for at least a decade, and helped ignite two recent mumps outbreaks that the allegedly ineffective vaccine was intended to prevent in the first place.

“As the single largest purchaser of childhood vaccines (accounting for more than 50 percent of all vaccine purchasers), the United States is by far the largest financial victim of Merck’s fraud. But the ultimate victims here are the millions of children who every year are being injected with a mumps vaccine that is not providing them with an adequate level of protection against mumps. And while this is a disease the CDC targeted to eradicate by now, the failure in Merck’s vaccine has allowed this disease to linger with significant outbreaks continuing to occur,” the suit alleges.

It refers to a 2006 mumps outbreak in the Midwest, in which 6,500 cases were reported among a highly vaccinated population, and another in 2009, in which 5,000 cases were confirmed. By comparison, the annual average of mumps cases in the U.S. in the two decades preceding the 2006 outbreak was 265; before the introduction of the single-shot Mumpsvax vaccine in 1967, there were approximately 200,000 cases of the disease, according to the 55-page document.

If the accusations are true — thus far Merck has denied wrongdoing — the case would lend credence to the perception held by many that pharmaceutical companies are more interested in pursuing profits and preserving their market share than in protecting consumers’ health.

Specifically, the suit claims Merck manipulated the results of clinical trials beginning in the late 1990s so as to be able to report that the combined mumps vaccine, known as MMR-II (a revised version of the 1971 MMR shot containing a different strain of the rubella virus), is 95 percent effective, in an effort to maintain its exclusive license to manufacture it. This percentage is the benchmark used by the FDA to grant Merck approval to sell its original mumps vaccine in 1967. It is believed by vaccine authorities to guarantee herd immunity for people who have skipped on the shots.

However, instead of reformulating the vaccine whose declining efficacy Merck itself has acknowledged, the company reportedly launched a complicated scheme to adjust its testing technique so that it would yield the desired potency results. The virologists say they witnessed firsthand the fraud and were asked to directly participate in the dishonest testing, which was dubbed “Protocol 007″ and is outlined in great detail in the complaint.

While the Justice Department has refused to rule on the case after conducting its own two-year investigation, the allegations are crucial for a couple of reasons.

Without doubt, if true, they offer an extremely damaging view into the inner process of a company accused of misleading both regulators and consumers about a vital medical product. This is exactly the kind of profit-centered, patient-careless attitude many consumer advocates, vaccine opponents, and non-believers of all stripes ascribe to Big Pharma.

But the suit also serves to remind that vaccines are essential to preventing disease and that any drop in their efficacy is likely to result in disease resurgence and endanger the public’s health.

Unfortunately, what should be a clear distinction between scientific truth and a single alleged case of scientific misconduct is all too readily muddied by anti-vaccination advocates who conflate the two in order to advance their particular kind of dogma.

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Gergana, are you saying that all the parents who sought for decades to have the truth about antidepressants killing their children, are anti-anti-depressants?

Are you saying that all those who fought with the car industry, to have seat belts and air bags are anti-cars?

Are you saying that all the people who fought Merck to prove that the drug Vioxx, which has maimed and killed so many and about which Merck serially LIED, are “anti-vioxx”

Of course this case is a boon to people who don’t vaccinate, and it’s not about the fact that they are anti-vaccine. It’s about the fact that it’s yet one more lie that BigPharma perpetrates, which should never have been lied about in the first place.

So don’t start pointing one finger at those who will legitimately use this information, which can rightly be used, because the ONLY reason it can be used points right back at Merck in the first place.

If the allegations are true, and they did indeed do this, then like all the other Merck fiascos in the past, Merck have only their own dishonesty and corruption to blame.

So how about talking about the real message, instead of indulging in journalistic epithet?

I knew the pro-vaccine camp would take this stance and say that because we criticize the lack of efficacy of this vaccine we are arguing for vaccination. But here’s the glitch: No vaccine has ever eradicated any disease on this earth…ever. Not mumps even though it’s been heavily used since 1967, not measles, not polio, and that’s right not even smallpox. Do vaccines suppress disease in some cases? Yes they do, like measles, but eradication is truly a fairy tale. Smallpox is not dead, but has been hiding under the witness protection program with dark glasses and a hat, and renamed monkeypox. No way the smallpox vaccine with all the damaging history and lack of efficacy it had and has been clearly demonstrated, and only given to a minority of the earth’s inhabitants eradicated smallpox. It’s still here. And in fact smallpox declined when vaccination stopped and living conditions and nutrition improved. The reason smallpox was declared eradicated was because many people in the information age were realizing that the vaccine was causing more problems than it could ever solve. Nobody has ever come up with anything remotely scientific about what titer is protective or about how often it was supposed to be given. But now that is all in the past now isnt’ it?

Enter the upcoming eradication of polio. Again, polio is still here and never went anywhere. It hides under many other names. Since you are fan of my writing please do visit IMCV and read up on the facts of polio. The plan to eradicate polio simply entails replacing the wild strains with vaccine strains that are and always will be completely capable of causing poliovirus outbreaks with concomitant paralysis in vaccinated communities. Isn’t the purpose of polio eradication to decrease the rate of paralysis? Well in the face of numerous polio vaccines in India, the rate of AFP is directly associated with those kids who get the most vaccines. So you tell me where polio has gone. And please while you are considering that, let us know what you learn about the change of diagnostic criteria that occurred after the vaccination came to be in 1954.

OK, measles not eradicated and never will be, mumps same. How can you eradicate a disease when the very vaccine you use can lead to outbreaks of the disease you are trying to eradicate? Mumps vaccine is associated with mumps outbreaks. It’s well documented in medical literature.

Chicken pox, not eradicated and never will be. Shingles only on the rise. Pertussis, don’t even try to defend that dud of a vaccine that leaves pertussis victims in the 86% vaccinated category.

Please tell us of any vaccine that has eradicated the disease you think it has and I will tell you exactly how it hasn’t.

The blind faith that people hold in vaccines is being eroded by stories like this Merck story because many parents know vaccines are not safe- but they think the diseases are terrible enough to take the chance. Now they know that there is no guarantee that the government that supports the vaccines is not hiding out with the crooked scientists that are cooking the books in order to pump dud vaccines into their children.

And the more their doubts are verified by issues like this, the more they will find out that the bogeymen diseases they have been told are so deadly – are not, and they will learn where to go and how to get their children through the illnesses. And then their kids will be all the stronger, less likely to be Merck’s customers for life long illnesses that occur as a result of their vaccines. Ask any autism parent what the cost of raising an autistic child is. Ask a parent of a dead gardasil vaccianted child what the emotional cost is. Autoimmune diseases very expensive, allergies and on and on – $$$ will be taken from Merck and put back in the pockets of the parents who blindly trusted and now know better. That has to hurt – Merck and friends.

I think that it is important that citizens have a basic science education so that they can:

1. understand the testing done that confirms monkeypox is not smallpox and follow the data to see that IMCV claims are an utter fabrication.

2. similarly understand how the testing done and basic thinking demonstrates that the claim that that the decrease in polio cases was do to changes in the diagnosis criteria is utterly bogus. And that the AFP rate is an artifact of testing–and example of the anti-vaccs complete inability to understand data.

3. all it takes is middle-school math to understand/analyze the distribution of outbreaks in highly vaccinated populations. Yet despite many decades of having the math explained to them, the anti-vaccs still can’t get the math or the logic correct.

4. there are a number of recent examples of modern, developed countries that have listened to the anti-vaccs and stopped (or markedly reduced) the use of vaccines. The only result is more sick or dead children. A stark reminder of the complete immorality of the anti-vacc arguments.

5. there are lots of basic log primers available on the web, that clearly explain the numerous Logical Fallacies in the IMCV arguments about autism, autoimmune disease, money….

Bottom line; IMCV is most harmless–it doesn’t stand up to any good-faith effort at fact-checking.

But then the truth is there are some people that still believe in homeopathy and the tooth fairy so one can’t conclude it is entirely harmless.

We can all look and see the absence of references/links in the anti-vacc postings here.

Thanks for reminding us that the hypocrisy of the anti-vaccs is infinite.

Anyway…since you are so kind to use the same handle, anyone that is really bored can look at your previous postings and see that no matter how many times over many years the obvious factual errors in your arguments are pointed out, you just keep advocating the same old falsehoods…..a good reminder why the world rejects you POV.

Thank you Whiteandnerdy! You speak the truth, but the truth is, the anti-vaccine people are simply a special set of conspiracy theorists. They do not follow the rules of logic, science, or math. Period. Too bad that so many people think they are right, just b/c they like Jenny McCarthy! Sheesh, what a bunch of maroons, as Bugs B would say. Take care.

Do you have any idea who Dr. Suzanne is? You say a basic understanding of science is needed? Dr. Suzanne is an M.D. who used to give vaccines to her own patients. I’d say she probably has a basic understanding of science. Everyone touts medical doctors as the only ones who would really have the ability to make an informed, science-based comment about issues like vaccination, so why then when medical doctors (and there are actually many of them) are against them they are said to be quacks or anti-science? It’s another double-standard.

This is purely speculative, but one can’t help but suppose that the DOJ spent a good part of their two year investigation doing potency testing on released lots of vaccine.

And after testing how every many lots they deemed necessary, they concluded the suit was entirely without merit and thus choose not to join it.

I would suggest waiting to see what evidence is presented and what the final ruling is.

My 2 cents: I think the correct way to characterize the “International Medical Council on Vaccination” is a group that makes money scaring parents about vaccines and who are complete strangers to the truth.

We’re in agreement. I don’t know whether the allegations are true or not, and I don’t presume that they are. I just think it’s fair when writing about such a charged topic to show what the vaccine manufacturer is being accused of, so one can judge for themselves whether the response from the vaccine skeptics makes sense.